Diagnostic meaning of indirect method for elastasa-1 pancreatic failure detection in faecal material of cystic fibrosis patients

Abstract

The aim of our work was to search specificity and sensitivity of pancreatic elastase-1 (E-1) immune enzyme detection (ScheBo^®BloTech, Germany) in faecal material both to define pancreatic failure in cystic fibrosis (CF) patients and to diagnose CF. The trial group included 128 children. The main subgroup involved 112 CF patients including 4 ones with CF pulmonary form aged from 3 months to 19 years. The control group involved 16. conventionally healthy children of the same age with no obvious digestive injury.

The E-1 concentration in all the control group children was within the normal range (more than 500 mcg/g of the faecal material), thus, the specificity of the method was 100%. Meanwhile, the sensitivity of the pancreatic failure detection in the CF patients was 86.6%. Moreover, we revealed the negative correlation (r =0.4; p<0.001) between E-1 concentration and a dose of a pancreatic enzyme drug (a lipase unit per 1 kg of the body weight in a day) taken by patients.

Therefore, the faecal detection of E-1 is a simple, exact and non-invasive method for pancreatic failure diagnosing in CF children; therapy with pancreatic enzyme drugs does not influence the result. The E-1 level detection can help to select a pancreatic enzyme replacing dose in CF patients. If the E-1 level is normal, the reasonability of pancreatic enzyme drug administration should be revised. When monitoring E-1 level in CF patients with preserved pancreatic function it is possible to administrate pancreatic enzyme drugs timely.